16 results
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37ms
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Sources: EU EUDAMED, US FDA
UROPOWER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MedGyn Pipette
FDA UDI
MEDGYN PRODUCTS, INC.·M803022721·MedGyn Pipette 3.1mm O.D.
MedGyn Pipette
Basic UDI-DI
EU MDD
·
Eu Md Class 1
·Medgyn International, Inc·1 device
AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EQUALIZER BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ALTRX +4 NEUT 44IDX64OD
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·March 27, 2013
MULTI-LINK 8
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MAF·March 17, 2011
SIX SHOOTER MULTI-BAND LIGATOR (DEVICE 1 OF 2)
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code MND·March 26, 2008
OT SURESTEP METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·March 31, 2011
OT SURESTEP ENHANCED METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·August 23, 2011
OT SS ENHANCED METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·April 11, 2011
OT SS ENHANCED METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·October 14, 2010
BD DISCARDIT¿ II SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·August 3, 2018
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·January 28, 2026
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Enforcement
Class II
·Terminated·Welch Allyn Protocol, Inc·January 15, 2014